Uterine manipulator with cutting head

ABSTRACT

A uterine manipulator can include a shaft including a first end, a second end, and embodiments of a cutting head configured and arranged to receive a cervix. The cutting head can be configured and adapted to be used to cut the tissue joining the vaginal wall to the cervix and uterus to facilitate removal of the uterus in a minimally invasive manner.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present patent application is a continuation of U.S. Pat. No.11,490,929, filed Aug. 3, 2020, which is a continuation of U.S. Pat. No.10,729,466, filed Mar. 28, 2010, which is a continuation of and claimsthe benefit of priority to International Patent Application No.PCT/US2018/47402, filed Aug. 21, 2018, which in turn claims the benefitof priority to U.S. Provisional Patent Application No. 62/548,252, filedAug. 21, 2017. Each of the foregoing patent applications is herebyincorporated by reference herein for any purpose whatsoever.

BACKGROUND

The present disclosure relates generally to uterine manipulators andmethods of using a uterine manipulator. Uterine manipulators can beused, for example, as aids in laparoscopic hysterectomies.

SUMMARY

Embodiments of the present disclosure can be used to mobilize andposition the uterus, to provide better visualization of the vagina andthe cervix for facilitating their separation, and to remove the uterusafter colpotomy is performed. An embodiment in accordance with thepresent disclosure can include a handle, a shaft, an inflatable balloon,and a cervical stop. The handle can be located at a proximal end of theshaft and the inflatable balloon can be located near the distal end ofthe shaft. The inflatable balloon can be maneuvered into the uterus in adeflated condition and then inflated (e.g., via saline or water injectedthrough the shaft) to help stabilize the uterine manipulator during aprocedure. The inflatable balloon can be used to remove the uterus afterit has been separated from the vagina. Once the uterine manipulator ispositioned, the cervical stop can be adjusted to abut the cervix.

Another embodiment of can include a handle, a shaft, an inflatableballoon, a cervical cup, and an occluder. The handle, the shaft, and theinflatable balloon can have similar functions as described above. Thecervical cup can be fitted around the cervix and pressed inward againstthe vaginal fornix in order to provide an observable or palpablelandmark of an incision point, such as that for dissecting the cervixand uterus from the vagina, and to physically separate the incision areafrom nearby ureters. An incision for detaching the uterus and cervixfrom the vagina can be executed laparoscopically (e.g., via a hookelectrode). The occluder, positioned within the vagina when the uterinemanipulator is set, can make continuous radial contact with the vaginalwall in order to maintain pneumoperitoneum after the incision betweenthe vagina and the cervix has been made. The occluder can be a siliconecup pushed up the shaft and pressed into the vagina, or a balloon slidonto the shaft and inflated so that it presses against the vaginal wall.

In some embodiments, a uterine manipulator is provided that includes ashaft including a first end, a second end, and a channel along an axisof the shaft, a handle coupled to the first end of the shaft, and atriangular balloon coupled to the second end of the shaft, thetriangular balloon being configured and arranged to match the shape ofan inner portion of a uterus upon inflation, wherein the triangularballoon is in fluid communication with a fluid reservoir containinginflation fluid by way of the channel, the fluid reservoir being coupledto an actuator, and further wherein the triangular balloon is configuredto be selectively inflated with fluid upon insertion into a uterus byactuating the actuator to cause the triangular balloon to conform to aninner surface of the uterus.

If desired, the proximal tip of the triangular balloon can be connectedto the shaft, and the distal end of the triangular balloon can includetwo distal tips located at outward corners of the triangular balloonpointing along a direction that is generally perpendicular to alongitudinal axis of the shaft, wherein, upon inflation, the distal tipsof the triangular balloon are sized and shaped to be located near theentrances to a patient's fallopian tubes. The two distal tips of thetriangular balloon can each include at least one aperture in fluidcommunication with a channel that traverses the balloon to a fluidreservoir near the proximal end of the manipulator that includes dyefluid and an actuator, wherein actuating the actuator causes dye fluidto flow out of the balloon and toward the fallopian tubes of a patientwhen the triangular balloon is deployed. If desired, the inflation fluidcan be the dye fluid and further wherein the fluid reservoir for theinflation fluid can be the same reservoir for containing the dye fluid.Alternatively, the inflation fluid and dye fluid can be two separatefluids in two separate fluid flow systems.

In some implementations, the two distal tips of the triangular ballooncan each include at least one aperture in fluid communication with aninterior portion of the triangular balloon, and further wherein theinflation fluid can include dye fluid, wherein actuating the actuatorcauses dye fluid to flow out of the balloon and toward the fallopiantubes of a patient when the triangular balloon is deployed. In someembodiments, the dye fluid can be suitable for use in achromoperturbation procedure. For example, the fluid can include atleast one of methylene blue and indigo carmine.

In further implementations, the uterine manipulator can further includea light source coupled to the second end of the shaft configured toilluminate an interior volume of the uterus. For example, the lightsource is positioned internally with respect to the triangular balloon.The light source can include at least one LED, for example. If desired,the light source can include a plurality of LEDs operably coupled to acontroller, the controller being configured to mix the colors of theLEDs to achieve a desired light output. In some embodiments, theplurality of LEDs can include LEDs having differing color outputattributes. The controller can have a control circuit that is operableto tune the temperature of the light of the plurality of the LEDs to adesired temperature. If desired, the controller can be operable to tunethe temperature of the light of the plurality of the LEDs to a desiredcolor.

In some implementations, a method of diagnosing a medical condition isprovided, including providing a uterine manipulator as set forth above,introducing the triangular balloon into the patient's uterus, andilluminating the light source to illuminate the patient's uterus. Themethod can further include viewing an inner surface of the uterus usingan optic to examine the endometrial lining of the uterus.

If desired, the method can include inspecting the patient's uterusexternally to search for fibroids, wherein the light source is ofsufficient intensity to illuminate the uterus internally.

If desired, the uterine manipulator can further include a channelcoupled to the second end of the shaft and a corner of the triangularballoon, and positioned internal to the triangular balloon, the channelconfigured and arranged to inject the dye into an opening of a fallopiantube. The shaft can include a groove, and the uterine manipulator canfurther include a cup. The cup can include a projection that interfaceswith the groove of the shaft and is configured to be positioned at ajuncture between a cervix and the vagina. If desired, the uterinemanipulator can further include a pneumooccluder coupled to the shaft, afirst end of a filling tube coupled to a fluid inlet, and a second endof the filling end coupled to the pneumooccluder.

The disclosure further provides embodiments of a uterine manipulator.The uterine manipulator typically includes a shaft including a proximalend, a distal end, and a channel along a longitudinal axis of the shaft,a handle coupled to the proximal end of the shaft, and a cutting headattached to the distal end of the shaft adapted to cut a tissue segmentto separate a vagina from a cervix and uterus. The cutting headtypically includes a cup coupled to the distal end of the shaft andconfigured to be positioned at a juncture between the cervix and avagina, and a cutting wire coupled to the cup via an aperture in the cupsuch that a portion of the cutting wire extends away from an exteriorsurface of the cup. The cutting wire is typically configured to follow asubstantially circular path about the longitudinal axis of the shaftwhen cutting through tissue to separate the cervix from the vagina.

If desired, a system can be provided including the uterine manipulatorsdescribed herein, and a power source coupled to the cutting wire toapply electrical current to a cutting wire portion of the uterinemanipulator. The uterine manipulator and power source can be configuredand arranged to provide monopolar current or bipolar current to apatient. A cup at a distal end of the uterine manipulator can beprovided that includes a metal ring coupled thereto. The metal ring canbe attached to a return path conductor that leads toward a proximal endof the uterine manipulator.

If desired, the cutting wire can be configured and arranged to traversea circumference of the distal portion of the cup along a groove definedbetween a distal end cap of the cup and a proximal frame portion of thecup. The uterine manipulator can further include a push wire slidablydisposed along the uterine manipulator, wherein a distal end portion ofthe push wire can be configured and arranged to carry a distal portionof the cutting wire outwardly from a distal end portion of themanipulator. The push wire can be configured to traverse an openingdefined through an end cap of the distal end portion of the uterinemanipulator. The cutting wire can be loaded into a distal end portion ofthe manipulator. Distal advancement of the push wire can carry thecutting wire distally and radially outward with respect to a distal endof the uterine manipulator.

The disclosure further provides methods of separating a uterus from avagina of a patient. The methods typically include providing a uterinemanipulator as described herein that include a cutting head, inserting adistal end portion of the uterine manipulator through a cervix of thepatient, and deploying the cutting wire through the tissue of the vaginaand/or cervix outwardly into an abdominal cavity of the patient.

If desired, a method can be provided that further includes visualizingthe cutting wire in the abdominal cavity through a laparoscopicprocedure including insufflating the abdominal cavity of the patient,and visually locating a portion of the cutting wire extending into theabdominal cavity. The method can further include grasping the cuttingwire using a second surgical instrument from within the abdominalcavity, and pulling the wire circumferentially around the cervix tosever the uterus and/or cervix from the vagina. In some implementations,the cutting can be accomplished without application of electricalcurrent to the uterine manipulator. In other embodiments, the cuttingcan be accomplished with application of electrical current to theuterine manipulator.

Some previous approaches may present drawbacks. Some previous approachesto intrauterine balloons do not conform to the uterine cavity andtherefore do not offer optimal mobilization of the uterus. Further,while some previous approaches offer chromopertubation, the dye isinjected from the tip of the manipulator and may be inadvertentlyinjected into the uterine muscle, which may affect fertility. Also,entry into the uterine cavity during a myomectomy is not easily detectedwith some previous approaches. In addition, some previous approaches mayonly serve to provide guidance for detaching the uterus and the cervixfrom the vagina via laparoscopic tools.

At least one embodiment in accordance with the present disclosureovercomes these drawbacks.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a uterine manipulator according to thepresent disclosure.

FIG. 2 is another perspective view of the uterine manipulator of FIG. 1.

FIG. 3 is an exploded perspective view of the uterine manipulator ofFIG. 1 .

FIGS. 4A and 4B are partial side views of a handle and a tip assembly,respectively, of the uterine manipulator of FIG. 1 .

FIGS. 5A and 5B are additional partial side views of the handle and thetip assembly, respectively, of the uterine manipulator of FIG. 1 .

FIGS. 6A-6C are side views of the uterine manipulator of FIG. 1 indifferent pivoting positions.

FIGS. 7A-7D are side and front views of the handle assembly of theuterine manipulator of FIG. 1 in different pivoting positions.

FIGS. 8A and 8B are side views of the uterine manipulator of FIG. 1 in aretracted position and an expanded position, respectively.

FIGS. 9A and 9B are perspective views of a cutting assembly and abackstop, respectively, of the uterine manipulator of FIG. 1 .

FIGS. 10A and 10B are side views of the cutting assembly and anelectrical connector assembly, respectively, of the uterine manipulatorof FIG. 1 .

FIG. 11 is a perspective view of a pneumooccluder of the uterinemanipulator of FIG. 1 .

FIGS. 12A-12D are cross-sectional views of a pelvic cavity and theuterine manipulator of FIG. 1 .

FIG. 13 is a perspective view of a manipulator, cup, and cuttingassembly in accordance with the present disclosure.

FIG. 14 is a series of views showing use of the cutting assembly of FIG.13 in accordance with the present disclosure.

FIGS. 15A-15B are side views of a uterine manipulator in accordance withthe present disclosure.

FIG. 16 illustrates a uterine manipulator in accordance with the presentdisclosure.

FIG. 17 illustrates the distal portion of the uterine manipulator andthe balloon in accordance with the present disclosure.

FIG. 18 illustrates the distal portion of a uterine manipulator and theballoon 418 in accordance with the present disclosure inserted into apatient's uterus.

FIG. 19A illustrates a partial perspective view of the uterinemanipulator of FIG. 16 .

FIG. 19B illustrates a cross-sectional view of the stopper and the keyof FIG. 16 .

FIG. 20 illustrates a cross-sectional view of the handle assembly ofFIG. 16 .

FIG. 21A illustrates a perspective view of the cup of FIG. 16 .

FIG. 21B illustrates another perspective view of the cup of FIG. 16 .

FIG. 21C illustrates a cross-sectional view of the cup of FIG. 16 .

FIG. 22 illustrates a distal portion of the uterine manipulator of FIG.16 .

FIG. 23 illustrates a partial side view of a cutting assembly inaccordance with the present disclosure.

FIG. 24 illustrates a perspective view of a cap of the cutting assemblyof FIG. 1 .

FIG. 25 illustrates a perspective view of a cutting assembly inaccordance with the present disclosure.

FIG. 26A is a side view of a further representative embodiment of auterine manipulator in accordance with the present disclosure, and FIG.26B is an enlarged view of the distal end as presented in FIG. 26A.

FIG. 27A is a side sectional, or cut-away view of the embodiment ofFIGS. 26A-26B, and FIG. 27B is an enlarged cut-away view of the distalend as presented in FIG. 27A.

FIG. 28 is a close up cross sectional view of the distal end portion ofthe uterine manipulator presented in FIG. 26A.

FIGS. 29A, 29B and 29C are a partial section isometric end view, apartial side section view and a full section view of the distal endportion of the uterine manipulator presented in FIG. 26A with thecutting wire partially deployed.

FIGS. 30A, 30B and 30C are a partial section isometric end view, apartial side section view and a full section view of the distal endportion of the uterine manipulator presented in FIG. 26A with thecutting wire partially deployed and the push wire retracted into thedevice after advancing the hot lead through tissue.

FIG. 31 is an isometric end view of the distal end portion of theuterine manipulator presented in FIG. 26A with the hot lead partiallydeployed as in FIGS. 30A, 30B and 30C.

FIGS. 32A-32B are outer and inner isometric views of a segment of thedistal end portion of the uterine manipulator presented in FIG. 26A withthe hot lead partially deployed as in FIGS. 30A, 30B and 30C.

FIGS. 33A-33B are outer and inner isometric views of the distal endportion of the uterine manipulator presented in FIG. 26A with theportion illustrated in FIGS. 32A-32B removed with the hot lead partiallydeployed as in FIGS. 30A, 30B and 30C.

FIGS. 34A-34B are upwardly directed isometric and side cutaway isometricclose up views of segments of the distal end portion of the uterinemanipulator presented in FIG. 26A with the portion illustrated in FIGS.32A-32B removed with the hot lead partially deployed as in FIGS. 30A,30B and 30C.

FIG. 35 is an isometric section view of the distal end portion of theuterine manipulator presented in FIG. 26A with the hot lead fullydeployed and positioned to cut through tissue to separate a cervix anduterus from a vaginal wall.

FIG. 36 is a side section view of the distal end portion of the uterinemanipulator presented in FIG. 26A with the hot lead fully deployed andpositioned to cut through tissue to separate a cervix and uterus from avaginal wall.

FIG. 37A is an isometric close up section view of the distal end portionof the uterine manipulator presented in FIG. 26A with the hot lead fullydeployed and positioned to cut through tissue to separate a cervix anduterus from a vaginal wall.

FIG. 37B is an isometric close up section view of the distal end portionof the uterine manipulator presented in FIG. 26A showing a portionopposite the hot lead, illustrating a portion of a conductive ringconnected to a further electrical conductor for providing a return pathfor applied power.

FIG. 38A is a further isometric close up section view of the distal endportion of the uterine manipulator presented in FIG. 26A with the hotlead fully deployed and positioned to cut through tissue to separate acervix and uterus from a vaginal wall.

FIG. 38B is a side close up sectional view of a distal end portion ofthe uterine manipulator presented in FIG. 26A with the hot lead fullydeployed and positioned to cut through tissue to separate a cervix anduterus from a vaginal wall, specifically illustrating a portion of aring-shaped, or toroidal gap defined between the hot lead and aconductive ring attached to a return conductor.

FIGS. 39A-39B illustrate a ring shaped end cap of the uterinemanipulator presented in FIG. 26A illustrating an opening therein foraccommodating passage of a push wire in accordance with the presentdisclosure.

DETAILED DESCRIPTION

FIGS. 1 and 2 illustrate a uterine manipulator according to the presentdisclosure. At least one embodiment can be used in laparoscopichysterectomies, robotic hysterectomies, laparoscopic myomectomies,and/or other pelvic procedures. The uterine manipulator 10 can include ahandle 12, a shaft 14, a tip assembly 16, a cutting assembly 18, apneumooccluder 20, and an electrical connector assembly 22. During use,the uterine manipulator 10 can be inserted into a patient's vagina 110,as shown in FIG. 12A, and then guided past the cervix 112 and into theuterus 114, as shown in FIG. 12B, using the handle 12. As shown in FIGS.12B and 12C, when the uterine manipulator 10 is inserted, the tipassembly 16 can be positioned in the uterus 114, the cutting assembly 18can be positioned adjacent to the vaginal fornix 118 and can pressagainst the cervix 112, and the pneumooccluder 20 can be positionedinside the vagina 110.

As shown in FIG. 3 , the tip assembly 16 can include an expansion tip24, a tip shaft 26, expansion elements 28, an abutment 30, and a tiphousing 32, and the handle 12 can include a handle housing 34, anexpansion actuator 36, a cap 38, a hinge 40, hinge pins 42, and apivoting element 44. The shaft 14 can be coupled to the tip assembly 16via the tip housing 32, and can be coupled to the handle 12 via thepivoting element 44. The tip assembly 16 can be coupled to the handle 12via connectors 46. As shown in FIGS. 4A and 4B, the connectors 46 can berouted from inside the handle housing 34, through the shaft 14, andcoupled to the tip housing 32. As shown in FIGS. 3, 5A and 5B, expansionconnectors 48 can be coupled to the expansion actuator 36, routed frominside the handle housing 34 through the shaft 14 and coupled to theexpansion tip 24 for actuating the tip assembly 16, as further describedbelow. In at least one embodiment, some or all of the components of theuterine manipulator 10 can be disposable. Some or all of the componentscan be removable from one another, for example, so that disposablecomponents can be uncoupled from permanent components and replaced withnew disposable components.

As shown in FIGS. 6A-6C, the tip assembly 16, the shaft 14, and thehandle 12 can be pivotable relative to each other at two separate pivotpoints 50, 52. The first pivot point 50 and the second pivot point 52can facilitate insertion of the uterine manipulator 10 into the uterus114 and can also facilitate repositioning of the uterus 114 during ahysterectomy. The first pivot point 50 can be located at the connectionbetween the tip housing 32 and the shaft 14. For example, as shown inFIGS. 4B and 5B, the end 54 of the tip housing 32 can be positionedbetween end components 56 of the shaft 14 so that through holes 58 ineach component 54, 56 are aligned, and a pin 60 can be routed throughthe through holes 58 to permit a pivotable connection.

The second pivot point 52 can be located at the connection between theshaft 14 and the handle 12. For example, as shown in FIGS. 4A, 5A, and7A-7D, the shaft 14 can be fixed to the pivoting element 44 (e.g., via apin 6 o and through hole 58 connection) and the pivoting element 44 canbe pivotable about the hinge 40 within the handle housing 34. The hingepins 42 can extend through the handle housing 34, the hinge 40, and atrack 62 of the pivoting element 44, as best shown in FIG. 7D. The track62 can be ribbed so that the pivoting element 44 cannot freely slidewithin it. Rather, the pivoting element 44 can be substantially fixed atspecific points along the ribbed track 62 and only adjusted by applyingan amount of force. This can prevent unwanted movement of the secondpivot point 52 unless a deliberate force is applied.

In at least one embodiment, an additional mechanism (for example, in thehandle 12), can be used to control both pivot points so, 52. Forexample, if the additional mechanism is actuated in a first direction,both pivot points so, 52 can be locked in place. If the additionalmechanism is actuated in a second direction, both pivot points so, 52can be unlocked and maneuverable. The shaft 14 can be constructed of anon-rigid, flexible material to facilitate insertion of the uterinemanipulator 10 into the uterus 114.

The tip assembly 16 can act as an umbrella-like expansion componentcapable of being adjusted between a retracted position and an expandedposition. As a result, the tip assembly 16 can replace conventionalintra-uterine balloon elements. The tip assembly 16 can be situated intothe retracted position, as shown in FIGS. 8A and 12B, to facilitateinsertion into the uterus 114 (e.g., until the abutment 30 reaches thecervix 112). Once inserted into the uterus 114, the tip assembly 16 canbe deployed into the expanded position, as shown in FIGS. 8B and 12C, tofacilitate a secure connection between the uterine manipulator 10 andthe uterus 114 and cervix 112.

The expansion elements 28 can be spring-like elements capable of beingin compression (e.g., shortened in length) and in tension (e.g.,lengthened). Pulling the expansion actuator 36 away from the handlehousing 34 can cause the expansion elements 28 to compress and expandoutward circumferentially, situating the tip assembly 16 into theexpanded position. Pushing the expansion actuator 36 back into thehandle housing 34 causes the expansion elements 28 to retract back intotension and lengthen, situating the tip assembly 16 into the retractedposition. Alternatively, the expansion actuator 36 can be twisted orrotated, rather than pulled and pushed from the handle housing 34, toadjust the expansion elements 28.

As shown in FIGS. 4B and 5B, the expansion tip 24 can slide into the tipshaft 26 until an end stop 64 of the expansion tip 24 reaches the end 66of the tip shaft 26.

The expansion elements 28 can fit over the tip shaft 26 until a firstend 68 of the expansion elements 28 reaches the end 66 of the tip shaft26. Both the expansion tip 24 and the tip shaft 26 can be slid into thetip housing 32, while the second end 70 of the expansion elements 28 canrest against an outer edge 72 of the tip housing 32. Pulling theexpansion actuator 36 outward from the handle housing 34 causes theexpansion connectors 48 to pull the expansion tip 24, and the tip shaft26, further into the tip housing 32. Because the expansion elements 28rest against the edge 72 of the tip housing 32, they are compressed(i.e., shortened in length) when the expansion tip 24 and the tip shaft26 are forced into the tip housing 32. Shortening of the expansionelements 28 causes them to expand in their circumferential direction,therefore situating the tip assembly 16 into the expanded position. Inthe reverse, pressing the expansion actuator 36 back into the housingreleases the pulling tension of the expansion connectors 48 on theexpansion tip 24. The expansion elements 28 can be in a resting statewhen in tension and thus, without the pulling tension by the expansionconnectors 48, the expansion elements 28 will revert back to theirresting, retracted state, thereby pulling the expansion tip 24 and thetip shaft 26 back out from the tip housing 32 and situating the tipassembly 16 into the retracted position.

Referring back to FIGS. 1 and 2 , the cutting assembly 18 can be slidover the shaft 14 and can be rotatable about the shaft 14. The cuttingassembly 18 can include a backstop 74, a tube 76, a cutting handle 78,fasteners 80, and a spring 81. The backstop 74 can be positioned at afirst end of the tube 76 and the cutting handle 78 can be positioned ata second, opposite end of the tube 76. The tube 76 can be slid over theshaft 14 and the cutting handle 78 can help maneuver the cuttingassembly 18 along and/or around the shaft 14. The fasteners 80 can helpfix the cutting assembly 18 in place along the shaft 14. The backstop 74can receive the cervix 112 and come in contact with the vaginal fornix118 when the uterine manipulator 10 is in position. The backstop canthen be maneuvered in a circular manner to cut around the cervix 112 fordetaching the cervix 112 and the uterus 114 from the vagina 110, asshown in FIG. 12D. As shown in FIGS. 10A and 10B, the backstop 74 caninclude a round cup portion 82 and a cutter 84 extending outward fromthe cup portion 82. During use, the cutting assembly 18 can be pressedup against the abutment 30 of the tip assembly 16 so that the cupportion 82 extends past the abutment 30 and engages the fornix,stretching and forcing the fornix upward and away from the ureters. Thecutter 84 can pierce through the tissue of the fornix, transecting theuterus 114 and the cervix 112 from the top of the vagina 110.

The cutting assembly 18 can be rotated about the shaft 14 (e.g., by thecutting handle 78), allowing the cutter 84 to travel in a circle at thejunction of the cervix 112 and the vagina 110 and permitting completetransection of the uterus 114 and the cervix 112 from the vagina 110.The spring 81 can help distribute rotational forces evenly across thetube 76 when the cutting assembly 18 is rotated, for example, to preventthe tube 76 from breaking due to excess torque concentrated along oneportion of the tube 76.

The electrical connector assembly 22 can advance the cutter 84 outwardfrom the cup portion 82 to achieve the detachment procedure describedabove, and can retract the cutter 84 inward to facilitate insertion ofthe uterine manipulator 10 into the uterus 114 without piercing thevaginal walls 120 prior to proper positioning of the uterine manipulator10. The electrical connector assembly 22 can provide an electricalconnection between the cutter 84 and an electrosurgical unit (not shown)in order to provide hemostasis during the detachment procedure. Theelectrical connector assembly 22 can include a handle 94, a cap 96, abutton 98, tubing 100, 102, and electrical connectors 104, 106. On oneend of the electrical connector assembly 22 (i.e., adjacent to the cap96), the tubing 100 and the electrical connectors 104 can be routed tothe electrosurgical unit. On the other end of the electrical connectorassembly 22, the tubing 102 and the electrical connectors 106 can berouted to the cutter 84. The electrical connectors 104, 106 can beelectrically connected through the button 98 so that current can berouted from the electrosurgical unit to the cutter 84. The electricalconnectors 106 can be coupled to the cutter 84 and the button 98 so thatpressing the button 98 forward and backward causes the cutter 84 toextend and retract, respectively.

Referring to FIG. 11 , the pneumooccluder 20 can include a balloon 86, afilling tube 88, and a bearing 90. The bearing go can be in contact withthe tube 76 of the cutting assembly 18, and the balloon 86 can bepositioned around the bearing 90. As shown in FIG. 11 , the bearing 90can include an outer groove 92 to allow passage of the electricalconnector assembly tubing. During use, the pneumooccluder 20 can bepositioned within the vagina 110 when the uterine manipulator 10 is setwithin the uterus 114. Once in position, the balloon 86 can be inflatedvia the filling tube 88 (e.g., with air, water, saline, or anotherfluid) in order to seal the distal vaginal cavity 122 from the proximalvaginal cavity 124. This can help maintain pneumoperitoneum once theincision has been made between the vagina 110 and the cervix 112 (i.e.,causing the proximal vaginal cavity 124 to be in fluid communicationwith the abdominal cavity). As a result of the bearing 90, the shaft 14and/or the cutting assembly tube 76 can be rotated without requiringrotation of the balloon 86. Because the balloon 86 can be set in placeand does not need to be rotated when the shaft 14 or the cuttingassembly 18 is rotated, the risk of losing pneumoperitoneum is greatlyreduced.

Thus, the uterine manipulator 10 can be inserted into a patient's vagina110 while in the retracted position, as shown in FIG. 12A. The uterinemanipulator 10 can then be further guided through the vagina 110, pastthe cervix 112, and into the uterus 114, while still in the retractedposition, as shown in FIG. 12B. Once set in the uterus 114, the uterinemanipulator 10 can be situated into the expanded position, as shown inFIG. 12C, in order to facilitate a secure connection between the uterinemanipulator 10 and the uterus 114. Once the uterine manipulator 10 isset within the uterus 114, the pneumooccluder 20 can contact the vaginalwall 120 in order to seal the uterus 114 from the outside environmentand the backstop 74 can abut the vaginal fornix 118, causing it tostretch upward. Once the uterine manipulator 10 is situated into theexpanded position, the cutter 84 can be extended and the cutting handle78 can be rotated in order to transect the uterus 114 and the cervix 112from the top of the vagina 110. The uterine manipulator 10 of thepresent invention and its above-described procedures can thus eliminatethe need for a colpotomy incision via laparoscopic tools, as inconventional laparoscopic and robotic hysterectomies.

At least one embodiment can include any combination of one or more ofthe above-described components and/or other conventional uterinemanipulator components. The above-described components, such as thecutting assembly 18, the tip assembly 16, and the pneumooccluder 20 canfunction independently from one another and therefore can beindividually incorporated into a uterine manipulator with or without theother components. For example, it may be preferable to include thepneumooccluder 20 as described above with some previous approaches tobest execute a specific pelvic procedure.

Referring to FIG. 13 , a cutting assembly 200 is illustrated. Thecutting assembly 200 can be used with the functional uterine manipulator10 of the preceding figures or can be used with other systems. Thecutting assembly 200 includes a cup portion 202 and an expansion tip 204extending therethrough. As illustrated in FIG. 13 , the expansion tip204 can be a balloon-type design or other configurations, such asdescribed above. Associated with the cup portion 202 is a cutter orcutter wire 206. The cup portion 202 is designed to engage the cervix112, such as previously described. The cutter 206 is formed as a narrowwire, with a looped tip, embedded between two grooves 208, 210 on thecup portion 202 (that is, around the circumference of the cup portion202).

FIGS. 15A-15B illustrate another uterine manipulator 300. The uterinemanipulator 300 can include a handle 312, a shaft 314, a tip assembly316, and a cutting assembly 318. Unless otherwise stated, the elementsof the uterine manipulator 300 can be similar in function and structureto those of the above-described uterine manipulator 100 of the previousfigures. The uterine manipulator 300 can incorporate any of theabove-described elements of the previous figures. For example, the tipassembly 316 can include an expansion tip 324, a tip shaft 326,umbrella-like expansion elements 328, an abutment 330, and a tip housing332. The handle 312 can include a handle housing 334 and an expansionactuator 336. Twisting or rotating the expansion actuator 336 in a firstdirection causes the expansion elements 328 to compress and expandoutward circumferentially, situating the tip assembly 316 into theexpanded position. Twisting or rotating the expansion actuator 336 in asecond, opposite direction causes the expansion elements 328 to retractback into tension and lengthen, situating the tip assembly 316 into theretracted position.

The cutting assembly 318 can be rotatable about the shaft 314. Morespecifically, as shown in FIGS. 15A-15B, the uterine manipulator 300 caninclude a flexible shaft portion 315 along which the cutting assembly318 can slide laterally and/or rotated for proper positioning oroperation. The cutting assembly 318 can include a cup portion 382 and acutter or cutter wire 384. Similar to the cutter 206 of FIG. 13 , thecutter 384 can be formed as a narrow wire, with a looped tip 383,embedded between grooves (not shown) on the cup portion 382. Inaddition, the cup portion 382 can include a projection 385 to assist anoperator in locating the cutter 384 during an operation, to help shieldthe cutter 384 during insertion of the uterine manipulator 300, and/orto help push the cutter 384 through the vaginal tissue.

Referring to FIG. 14 , the cutter 206 (or the cutter 384) is preset in astored position 212 between the grooves 208, 210 (for example, when theuterine manipulator 100/300 is being inserted into a patient's uterus114). The cutter wire can be secured between the grooves 208, 210 bysmall, thin bridges (not shown) around the edge of the cup portion 202,with the looped tip of the cutter 206 extending outward from the grooves208, 210 at a 12 o'clock position. The bridges can be thin enough thatthey can be easily broken by pulling the cutter 206 against the bridgeswith sufficient force. The cutter 206 is designed to move from thestored position 212 to an extended position 214 where the cutter 206 canbe pushed through the top of the vagina (for example, with the help ofthe projection 385 of cup portion 382 shown in FIGS. 15A and 15B) afterthe cup portion 202 has been positioned at a juncture between the cervix112 and the vagina 110 (for example, the vaginal fornix 118). In afurther extended position 216, the cutter 206 can be pulled in by alaparoscopic instrument 218, or “wand,” that is introducedlaparoscopically.

The instrument 218 includes a trocar 220 that extends through the skin222 to present a handle 224 to a clinician. The instrument 218 alsoincludes a small grasper 217 at its proximal end that can grasp orengage with the looped tip of the cutter 206. Using the handle 224, theinstrument 218 is directed around the cup portion 202 and, as a result,pulls the cutter 206 at position 226. As the cutter 206 makes contactwith tissue at the juncture of the vagina 110 and cervix 112, the tissueis cut, thus separating the vagina 110 from the cervix 112 and uterus114. At a final position 228, for example, once the cutter 206 has beenpulled around the circumference of the cup portion 202, the cutter 206can be separated from the cup portion 202. The laparoscopic instrument,with the entire cutter 206, can then be removed through a laparoscopicport at the skin 222.

The inner groove 210 of the cup portion 202 can be taller than the outerGroove 208 to prevent the cutter 206 from being pulled inward (insteadof upward or outward) as the instrument 218 pulls the cutter 206. Inaddition, the laparoscopic instrument 218 can include an outerinsulation cover 219 that is pushed forward while the cutter 206 ispulled out of the grooves 208, 210. That is, the cutter 206 is pulledinto or received in the laparoscopic instrument 218 so that the cutter206 is covered by the laparoscopic instrument 218 during operation,thereby enhancing safety given that the cutting wire or blade (which canbe carrying electrical current, as described below) is not exposed atany given time.

The cutter 206 can either cut the vagina without electrical current(“cold”) or with an electrical current, based on surgeon preference. Forexample, a distal end of the laparoscopic instrument 218 can connect toan electrosurgical unit (not shown) or electrical connector assembly,which can conduct monopolar or bipolar current. Accordingly, once thelaparoscopic instrument 218 grasps the cutter 206, current is passedthrough the instrument 218 and to the cutter wire 206. Differentoperations can be conducted based on monopolar or bipolarconfigurations. For example, in a monopolar configuration, the cutter206 can be pulled out of the cup portion 202 along its entirecircumference and removed via the laparoscopic instrument 218 (asdescribed above with reference to FIG. 14 ) while the cup portion 202remains fixed to a shaft (such as shaft 14 or 314). More specifically,the cup portion 202 is not rotated about the shaft during thisoperation. Power during monopolar operation can be relatively high, suchas about 100 watts.

FIG. 16 illustrates a uterine manipulator 400 in accordance with thepresent disclosure. The uterine manipulator 400 can include a handleassembly 402 coupled to a distal end of a shaft 406. The handle assembly402 is discussed further in association with FIG. 18 below. The handleassembly 402 and the shaft 406 can be analogous to the handle 12 and theshaft 14 illustrated in FIGS. 1-2 , respectively. The shaft 406 can besubstantially S-shaped. The uterine manipulator 400 can include a sheath410, which can slide over and along the exterior surface of the shaft406. The sheath can be heat shrunk around the shaft 406. The uterinemanipulator 400 can include a stopper 408 that slides over and along theexterior surface of the shaft 406 and interfaces with the distal end ofthe sheath 410. The stopper 408 includes a key 407 that can engage withthe shaft 406. Engaging the key 407 with the shaft 406 can prevent thestopper 408 and the sheath 410 from sliding distally along the exteriorsurface of the shaft 406. The stopper 408 and the key 407 are discussedfurther in association with FIGS. 17A-17B below.

The uterine manipulator 400 can include a pneumooccluder 412, which canslide over and along the exterior surface of the sheath 410. A fillingtube 422 can be coupled to the pneumooccluder 412 and can include fluidinlet 420 for the pneumooccluder 412. The pneumooccluder 412 and thefilling tube 422 can be analogous to the pneumooccluder 20 and thefilling tube 88 illustrated in FIGS. 1-2 , respectively. A cup 414coupled to the sheath 410 at or near the distal end of the sheath 410.The cup 414 can be configured to be positioned at a juncture between apatient's cervix and vagina. The cup 414 can include a cap 416. The cap416 can be coupled to the cup 414 at a distal end of the cup 414. Thecup 414 is discussed further in association with FIGS. 19A-20 below. Atleast one embodiment does not include the cup 414 and the cap 416.

FIG. 17 illustrates the distal portion of a uterine manipulator and theballoon 418 in accordance with the present disclosure. The balloon 418can be triangular in shape. The triangular shape can mimic the interiorcontours of a patient's uterus. The triangular shape can be similar tothat of an isosceles triangle, for example. The corners 452-1 and 452-2of the balloon 418, where the base 453 meets each of the legs 454-1 and454-2, can be rounded or cut off to better mimic the interior contoursof a patient's uterus. The balloon 418 can be coupled to a tube 450 atthe point 451 where the legs 454-1 and 454-2 of the balloon 418 meet. Asshown in FIG. 17 the tube can protrude into the volume of the balloon418 such that that the distal end of the tube 450 almost contacts thebase 453 of the balloon 418. The tube 450 can include steel. The tube450 can be coupled to the shaft 406 or comprise the shaft 406. Theballoon can include a thermoplastic polyurethane (TPU) material.

FIG. 18 illustrates the distal portion of a uterine manipulator and theballoon 418 in accordance with the present disclosure inserted into apatient's uterus 531. The distal portion of the uterine manipulator,such as the uterine manipulator 400 illustrated in FIG. 16 , can beinserted into a patient's uterus 531 via the patient's vagina 540 andcervix 538. As illustrated in FIG. 18 , the corners 452-1 and 452-2 ofthe balloon 418 can include apertures and/or channels 536. For example,dye can be injected into the balloon 418 via the channels 536, such asthat used in chromopertubation in order to determine the patency of oneor both fallopian tubes. Because the balloon 418 mimics the interiorcontours of a patient's uterus 531, the corners 452-1 and 452-2 can bealigned with the openings of the fallopian tubes 534 with little or noadjustment of position and/or orientation of the inflated balloon 418 inthe patient's uterus 531. Thus, when dye is injected into the balloon418 the dye flows directly from the corners 452-1 and 452-2 into theopenings of the fallopian tubes 534 so as to avoid inadvertent injectionof dye into muscular tissue of the uterus.

As illustrated in FIG. 18 , the balloon 418 can include a light source532, such as a light emitting diode (LED) or fiber optics. The lightsource 532, for example, can be coupled to the tube 450. The lightsource 532 can illuminate the interior of a patient's uterus 531. Thelight output of the LED (or LEDs) can range from about 100 lumen toabout 10,000 lumen, in increments of about one lumen. An array of LEDelements can be provided coupled to a controller that can controllablyadjust the temperature (e.g., 2700 K to 5000 K in increments of 10K)and/or color of the LEDs to produce, for example, shades of white lightof varying warmth by relatively increasing the amount of yellow or blueoutput of the LEDs. Thus, an LED array having LEDs of different colors(yellowish white to bluish white) can be provided. For example, thearray can have three (red, green blue LEDs), four, five, six, seven,eight, nine, ten, eleven or twelve different colors of LEDs to permitcolor mixing. For example, the controller can create a light outputhaving a peak light output between about 365 nm and about 700 nm inincrements of about 5 nm.

Using visualization from inside a patient's uterus 531 (e.g., using aseparate endoscope, using an endoscope disposed along a separate sleeveformed into the shaft, or by using an optic integrated into the balloon,such as a photodetector array, not show), in addition to or as acomponent of the uterine manipulator, the endometrial lining of thepatient's uterus 531 can be examined, for example, for perforationsduring a myomectomy. Avoiding undetected perforations in the endometriumcan increase patient safety and/or the fertility of the patient. If thelight source has a high intensity, a patient's uterus can be illuminatedinternally but visualized externally to, for example, identify and/orlocate fibroids, such as the fibroid 530. Such external visualizationcan be accomplished, for example, but introducing an endoscope into aninsufflated abdominal cavity. The camera of the endoscope can thus viewlight originating from within the uterus and shining through the tissueof the uterus.

FIG. 19A illustrates a partial perspective view of the uterinemanipulator 400 of FIG. 16 . As shown in FIG. 19A, the shaft 406 caninclude a groove 432. The groove 432 can run along a portion of theshaft 406 beginning at the proximal end of the shaft or the full lengthof the shaft 416. The groove 432 can be used to orientate rotationallyat least one component of the uterine manipulator 400, such as thehandle assembly 402 or the cup 414. The key 407 can engage with theshaft 406 via a protrusion 431 of the key 407 that fits in the grove432. The stopper 408 can have a sloped distal end.

FIG. 19B illustrates a cross-sectional view of the stopper 408 and thekey 407 of FIG. 16 . As shown in FIG. 19B the shaft 416 interfaces thestopper 408 via a gasket 434. The gasket 434 can prevent liquid/gasleaks from the sheath 410. The proximal end of the sheath 410 interfaceswith the distal end of the stopper 408. As shown in FIG. 19B, the shaft416 can include a channel 433. The channel of the shaft 406 can, forexample, transport fluid to inflate the inflatable balloon 418. The key407 can include a protrusion 435 that engages the shaft 406 via thegroove 432.

FIG. 20 illustrates a cross-sectional view of the handle assembly 402 ofFIG. 16 . The handle assembly 402 can include a fluid inlet 404, whichcan be located at the proximal end of the handle assembly 402. Thehandle assembly 402 can include a proximal portion of the shaft 402illustrated in FIG. 16 . As shown in FIG. 20 , the proximal end of theshaft 406 can be coupled to a locking block 436. An inlet tube (notshown) can be coupled to the locking block 436 and the fluid inlet 404.The locking block 436 can include a channel to allow fluid and/or otherequipment (e.g., a stylet) to pass through the fluid inlet 404, theinlet tube, and the locking block 436 and into the shaft 406. The handle435 can surround at least a portion of the fluid inlet 404, the inlettube, the locking block 436, and the shaft 406. Although not shown inFIG. 20 , the handle assembly 402 can include apertures and/or channelsfor wires 450-1 and 450-2 illustrated in FIG. 22 .

Although not illustrated in FIG. 20 , the handle assembly 402 caninclude a trigger. The trigger can be coupled to a needle in the cup 414as described in association with FIG. 16 above. The needle in the cup414 can be used to introduce the wire.

FIG. 21A illustrates a perspective view of the cup 414 of FIG. 16 . Thecup 414 can have a conical shape. The distal end of the cup 414 includesan interface 440 for the cap 416 illustrated in FIG. 16 . The cup 414 isconfigured to interface with a patient's cervix.

FIG. 21B illustrates another perspective view of the cup 414 of FIG. 16. The cup 414 can include aperture 446 through which the shaft 416 canpass through. As shown in FIG. 21B the cup 414 can include apertures442-1 and 442-2 for passing wires through for powering a cutting head(discussed further in association with FIG. 22 below) or for any otherdesired purpose.

FIG. 21C illustrates a cross-sectional view of the cup 414 of FIG. 16 .As shown in FIG. 21C, the aperture 446 can include a first diameter 447for the shaft 406 and a larger second diameter 448 (e.g., a counterbore) for a sheath 410 illustrated in FIGS. 16 AND 22 . The aperture 446can include a projection 445 that can fit into the groove 432illustrated in FIG. 19A to maintain proper orientation of the cup 414relative to the shaft 406.

FIG. 22 illustrates a distal portion of the uterine manipulator 400 ofFIG. 16 . The pneumooccluder 412 the cup 414 are shown as see-through.However, embodiments are not limited to the pneumooccluder 412 and/orthe cup 414 including a transparent material. In at least oneembodiment, the uterine manipulator 400 can include a heat shrink sleeve452 that surrounds the sheath 410 from the stopper 408 to the cup 414.As shown in FIG. 22 wires 450-1 and 450-2 pass through apertures in thestopper 408, run adjacent to the heat shrink sleeve 452, pass under thepneumooccluder 420, and pass through the apertures 442-1 and 442-2,respectively. It will be appreciated that conductors/wires can be routedin other manners.

In a bipolar configuration, the cutter 206 can be a shorter wire thanthe monopolar configuration, for example, about 2 centimeters (cm) toabout 3 cm. The cutter 206 can be pulled through the vaginal tissue bythe laparoscopic instrument 218, remaining at the 12 o'clock position,and then the cup portion 202 can be rotated about the shaft as thecutter 206 is held in place. One pole of the bipolar current can bethrough the laparoscopic instrument 218 (connected to the cutter wire206) and the other pole can be through the cup portion 202.

In at least one embodiment, the shorter cutter 206 can be held betweenthe grooves 208, 210 by a small ball (not shown) at a distal end of thecutter 206. The ball can help the cutter 206 slide around thecircumference of the cup portion 202 but also prevents the entire cutter206 from being pulled out from between the grooves 208, 210 as thelaparoscopic instrument 218 pulls the cutter 206. Once the cutter 206has traversed the entire circumference of the cup portion 202, a breakor opening (not shown) between the grooves 208, 210 can allow the ballto be pulled out from the cup portion 202 and into the laparoscopicinstrument 218 for removal. This ball configuration can be used withbipolar or monopolar applications. In bipolar applications, a smallmetal lining inside of the grooves 208, 210 can electrically connect thecup portion 202 to the ball (which is electrically connected to thelaparoscopic instrument 218).

The uterine manipulator 10, 300, 400, or at least one or more componentsof the uterine manipulator 10, 300, can be used with orifice-assistedsmall incision surgeries (OASIS). In such surgeries, instrumentation canbe inserted through a patient's belly button as well as the patient'svagina 110. The optical axis (e.g., of a laparoscope inserted throughthe belly button) can be decoupled from the operative axis (e.g., of asurgical tool inserted through the vagina 110). The uterine manipulator10, 300 can include an extension tool to assist with OASIS procedures.

FIGS. 23-25 illustrate an embodiment of a cutting head that is suitablyconfigured for use with the uterine manipulators disclosed herein, orother uterine manipulators or other medical devices that utilize, or canbe modified to utilize, an electrosurgical cutter. It will also beappreciated by those of skill in the art that the disclosed cutting headcan be used in a variety of other procedures other than proceduresseparating the uterus from the vagina, such as bowel resections, gastricbypass procedures and any other procedure that requires separation ofbiological structures having a tubular or ring shaped component to becut.

For purposes of illustration, and not limitation, FIG. 23 illustrates apartial side view of a cutting assembly 500 in accordance with thepresent disclosure. The cup 506 can be configured to be positioned at ajuncture between a patient's cervix and vagina. The cutting assembly 500can include a cutting wire 504. As illustrated in FIG. 23 , the cuttingwire 504 can pass through an aperture of the cup 506. The cap 502 caninclude an electrically insulating material disposed thereon (e.g.,parylene, or other suitable material). The cutting wire 504 can contact(rest against) the electrically insulating material on the cap 502. Thecutting assembly 500 can include a projection 501 that initially pushesthe cutting wire 504 through the tissue when the cup 506 is positionedat the juncture between the cervix and the vagina.

The cutting wire 504 can be used to cut the vagina without electricalcurrent (“cold”) or with an electrical current (“hot”), based on surgeonpreference. Different operations can be conducted based on monopolar orbipolar configurations. Power during monopolar operation can berelatively high, such as about 100 watts. As the cutting assembly 500rotates about the shaft 406, the cutting wire 504 follows asubstantially circular path thereby separating a patient's uterus andcervix from the vagina.

FIG. 24 illustrates a perspective view of a cap 502 of the cuttingassembly 500 of FIG. 23 . The cap 502 can include a base 514 and anelectrically insulating (e.g., plastic, parylene) coating 508. The base514 can include an electrically conductive material, such as a stainlesssteel foil. The electrically insulating coating 508 can be bonded to asurface of the base 514. The base 514 can include one or more tabs512-1, 512-2, and 512-3 for coupling the cap 502 to an interior surfaceof the cup 506 as discussed further in association with FIG. 25 below.The tabs 512-1, 512-2, and 512-3 can include an aperture through which afastener (e.g., a screw) can pass.

FIG. 25 illustrates a perspective view of a cutting assembly 550 of auterine manipulator in accordance with the present disclosure. Thecutting assembly 550 can include a cup 554 and a cap 556. The cup 554and the cap 556 can be analogous to the cup 506 and the cap 502illustrated in FIG. 23 , respectively. Fasteners 552-1, 552-2, and 552-3can couple the cap 556 to the interior surface of the cup 554 throughapertures in the tabs 512-1,512-2, and 512-3. A cutting wire 504 can becoupled to one of the fasteners, such as the fastener 552-3. Forexample, the cutting wire 504 can be coupled to an eyelet (not shown).The eyelet can be placed around the fastener 552-3. An electric currentcan be applied to the cap 556 (e.g., to an electrically conductivematerial of the base 514 described above). The cap 556 can electricallyinsulating material to prevent harm and/or injury to a patient from theelectric current. The cutting wire 504 can include a looped tip, whichcan be used to engage a laparoscopic instrument. As indicated by thedouble-headed arrows in FIG. 25 , the cutting assembly 550 can rotate,clockwise and/or counterclockwise. As the cutting assembly 550 rotates,for example about the shaft 406, the cutting wire 504 follows asubstantially circular path thereby separating a patient's uterus andcervix from the vagina.

FIG. 26A is a side view of a further representative embodiment of auterine manipulator in accordance with the present disclosure, and FIG.26B is an enlarged view of the distal end as presented in FIG. 26A.

As illustrated, the uterine manipulator 600 bears a number ofsimilarities to previous embodiments, including a triangular balloonconnected to an actuator 620 housed within a distal cup. It will beappreciated that structures other than a triangular balloon can be used.Focusing on the distal end portion 650 of the manipulator 600, FIG. 26Billustrates a side view of a cup that has been configured to provide abipolar cutting mechanism discussed in further detail below. It will beappreciated that instead of providing a bipolar arrangement including aconductive ring 690 and a return conductor 668, this design can bemodified to be a monopolar cutting head by removing those components andmaking other suitable modifications. FIG. 27A is a side cut away view ofthe embodiment of FIGS. 26A-26B, wherein FIG. 27B is an enlarged view ofthe distal end as presented in FIG. 27A showing the location ofcomponents discussed in particular detail below.

With reference to FIG. 28 , a close up cross sectional view of thedistal end portion of the uterine manipulator presented in FIG. 26A ispresented. Distal end portion 650 includes a cutting head formed by astationary cup, as opposed to a rotating cup in the precedingembodiment. Procedurally, a hot lead is deployed and advanced by a pushwire (e.g., made of stainless steel) through the vaginal wall where itintersects the cervix. The hot wire is externalized so it can be viewedlaparoscopically within the abdominal cavity, and where it can begripped and pulled around (e.g., with forceps or other tool) around thecircumference of the distal cup. This avoids the use of a rotatingcutting head, and wire that is pre-packed into the distal cutting headis externalized and pulled through as the circumference of the cervix istraversed. Cutting is achieved with the aid of an arc discharge that ispresent in a toroidal gap (e.g., 692) defined between the hot wire 660and a conductive ring 690 as the hot wire is pulled around thecircumference of the cervix.

Thus, the components illustrated in FIG. 28 , and later figures, includethe distal cutting head 650 that terminates in an annular, or toroidal,distal cap 654 that preferably includes a coating of insulating materialon its proximally and/or distally oriented faces. Beneath the cap withinthe distal cup is defined an annular trench, or channel, that isconfigured to receive a conductive ring 690. Ring 690 may be a discretemetallic component or may be metallized on a plastic surface. Ring 690essentially sits in a trough having a radially outwardly located lipthat extends upwardly from the bottom of the trough, and is preferablymade from a dielectric material. The radially outwardly located lipcooperates with the circumferential periphery of the distal cap todefine an annularly shaped groove therebetween that can permit cuttingwire 660 to be drawn through as the device is used to make a 360 degreecut to separate the cervix from the vagina. It will be appreciated thatthe groove could be slightly less than 360 degrees, if desired, toenhance structural stability. In use, once deployed, the conductive hotlead 660 is pulled radially outwardly through and along the annularlyshaped groove. As this happens and power is applied to the hot lead 660and a return path is defined along ring 690 and conductor 668 (see FIG.37B), a space always exists between the hot lead 660 and the conductivering 690. When the applied electric field is sufficiently high, currentwill flow across the gap 692 from the wire 660 to the ring 690. In theprocess of doing this, a plasma may or may not be formed locally(depending on the voltage and pulse shape of the applied waveform) whichcan provide enhanced benefits of reactive oxygen species (ROS) and thelike, as well as generally providing the benefits of electrocauteryeffects to minimize bleeding from the vaginal wall and the severedcervix/uterus.

As illustrated, conductor 660 terminates in a cuff 680 that is in turnengaged by a distal tip 672 of a push rod 670. End cap 654 defines anelongate opening therein that is disposed along a radial direction. Theelongate opening is configured to permit the push rod 670 to passthrough it, carrying the cuff 680 and a distal end 664 of the hot leador conductor 660. While a proximal end of the hot lead 660 is shown notextending proximally to the proximal end of the device, this is tosimplify illustration. In operation, the proximal lead 660 eitherextends through the proximal end of the device or follows a conductivepath through the proximal end of the device 600 where it is connected toa hot lead of a suitable electrosurgical signal generator, or powersupply (not shown). Likewise, the lead 668 (FIG. 37B) also extendsthrough the proximal portion of the device 600 and is electricallycoupled to a return terminal of the signal generator/power supply tocomplete the bipolar circuit, and avoiding the need for a grounding pad,thereby minimizing the amount of electrical energy directed through apatient. Likewise, although not specifically illustrated in thedrawings, the push rod 670 also extends proximally to an actuator, notshown, to permit it to be moved distally and proximally with respect tothe device to deploy the hot wire.

FIGS. 29A, 29B and 29C are a partial section isometric end view, apartial side section view and a full section view of the distal endportion of the uterine manipulator presented in FIG. 26A with thecutting wire partially deployed.

As illustrated in FIG. 29A, the hot wire 660 can be folded in and/ordoubled over along the path of the annular gap 692, but preferablylocated radially inwardly. In operation, FIG. 28 shows the hot wire 660in a pre-deployed condition, wherein the hot wire is located, or wrappedinside of, the annular gap, and extends radially outwardly from the gap,and wrapped over the radially outwardly solid portion of the end cap 654(shown in FIGS. 39A-39B) that is defined in part by the radiallyoriented opening through the end cap. The hot wire 660 then wrapsproximally and is received by the cuff 680, which is removably attachedto the distal tip 672 of the push rod 670. The push rod 670 (which maybe made from stainless steel, for example) is then advanced distally outof the radially oriented gap defined through the end cap 654, pullingalong the distal end 664 of the hot lead 660 through the gap 692. Asillustrated, the push rod 670 can have a pre-formed curvature thatcauses it to bend radially outwardly, to pierce tissue near the cervixand pass radially outwardly into the abdominal cavity. While surroundingtissue is not illustrated, it will be appreciated that when the wire 660has been pushed through the tissue into the abdominal cavity by the pushrod 670, it will become visible to a surgeon that is viewing within theabdominal cavity after insufflation using an endoscope and a lightingdevice through a trocar.

FIGS. 30A, 30B and 30C are a partial section isometric end view, apartial side section view and a full section view of the distal endportion of the uterine manipulator presented in FIG. 26A with thecutting wire partially deployed and the push wire retracted into thedevice after advancing the hot lead through tissue.

FIGS. 30A-30C illustrate the hot wire lead 660 and cuff 680 left in aposition that is externalized in an abdominal cavity (withoutillustrating surrounding tissue for clarity). The push rod 670 iswithdrawn back into device 600. This permits a surgeon to then grip thecuff 680 (which may be made from insulating material or with aninsulating coating) to then pull the wire around the circumference ofthe annular gap, either cold (without applied electrical power), or hot(with applied electrical power). FIG. 31 is an isometric end view of thedistal end portion of the uterine manipulator presented in FIG. 26A withthe hot lead partially deployed as in FIGS. 30A, 30B and 30C prior tobeing gripped by a surgeon to cut tissue along a circumferentialdirection. FIG. 31 also illustrates a portion 352 of the cup that can beremovable, or permanently attached, to help locate the conductors inplace, if desired. This segment is further illustrated in FIGS. 32A-32Bwhich are outer and inner isometric views of a segment of the distal endportion of the uterine manipulator presented in FIG. 26A with the hotlead partially deployed as in FIGS. 30A, 30B and 30C.

FIGS. 33A-33B are outer and inner isometric views of the distal endportion 650 of the uterine manipulator 600 presented in FIG. 26A withthe portion illustrated in FIGS. 32A-32B removed with the hot lead 660partially deployed as in FIGS. 30A, 30B and 30C to illustrate relativeplacement of components. Similarly, FIGS. 34A-34B are upwardly directedisometric and side cutaway isometric close up views of segments of thedistal end portion 650 of the uterine manipulator 600 presented in FIG.26A with the portion illustrated in FIGS. 32A-32B removed with the hotlead 660 partially deployed as in FIGS. 30A, 30B and 30C.

Moving along through an illustrative procedure, FIG. 35 is an isometricsection view of the distal end portion 650 of the uterine manipulator600 presented in FIG. 26A with the hot lead 660 fully deployed along aradially outward direction with tension applied thereto at cuff 680through various means, such as a forceps (not illustrated) andpositioned to cut through tissue to separate a cervix and uterus from avaginal wall. FIG. 36 is a side section view of the distal end portion650 of the uterine manipulator 600 presented in FIG. 26A with the hotlead 660 fully deployed and positioned to cut through tissue to separatea cervix and uterus from a vaginal wall. FIG. 37A is an isometric closeup section view of the distal end portion 650 of the uterine manipulator600 presented in FIG. 26A with the hot lead 660 fully deployed andpositioned to cut through tissue to separate a cervix and uterus from avaginal wall. FIG. 37B is an isometric close up section view of thedistal end portion 650 of the uterine manipulator 600 presented in FIG.26A showing a cutaway portion of the distal cup opposite the hot lead660, illustrating a further portion of the conductive ring 690 connectedto the further electrical conductor 668 for providing a return path forapplied power as described above.

FIG. 38A is a further isometric close up section view of the distal endportion of the uterine manipulator presented in FIG. 26A with the hotlead fully deployed and positioned to cut through tissue to separate acervix and uterus from a vaginal wall.

FIG. 38B is a further side close up sectional view of a distal endportion 650 of the uterine manipulator 600 presented in FIG. 26A withthe hot lead 660 fully deployed and positioned to cut through tissue toseparate a cervix and uterus from a vaginal wall, specificallyillustrating a portion of a ring-shaped, or toroidal gap 692 definedbetween the hot lead 660 and the conductive ring 690 attached to areturn conductor 668. FIGS. 39A-39B illustrates the ring shaped end cap654 of the uterine manipulator presented in FIG. 26A illustrating theopening 656 therein for accommodating passage of a push wire inaccordance with the present disclosure.

It will be appreciated the cutting head of FIGS. 28-39 can be suitablycombined with any of the features present in the earlier embodiments ofthe present disclosure. Stated another way, any of the embodiments ofFIGS. 1-22 can be modified to include the cutting head of FIGS. 28-39 .

The present disclosure has described one or more preferred embodiments.However, it should be appreciated that many equivalents, alternatives,variations, and modifications, aside from those expressly stated, arepossible and within the scope of the invention.

1. A uterine manipulator, comprising: a shaft; a handle coupled to aproximal end of the shaft; a return path conductor extending along theshaft; and a cutting head coupled to a distal end of the shaft, thecutting head including: a cup coupled to a distal end of the shaft,wherein the cup is configured to be positioned at a juncture between acervix and a vagina; a conductive ring to which the return pathconductor is electrically coupled; a cutting wire conforming to andextending around at least a portion of the cup when in a storedposition, wherein the cutting wire is configured to follow asubstantially circular path when unwound about a longitudinal axis ofthe shaft; and wherein the cutting wire and the conductive ring definean annular gap sized to facilitate an arc discharge between the cuttingwire and conductive ring when the cutting wire is energized.
 2. Theuterine manipulator of claim 1, wherein the cutting head furtherincludes an annular trench in which the conductive ring is received. 3.The uterine manipulator of claim 1, wherein the cutting wire has anextended position in which the distal portion of the cutting wireextends outwardly from the cup, the uterine manipulator furthercomprising a push wire slidably disposed along the shaft, the push wirehaving a distal portion configured to engage the distal portion of thecutting wire so that the push wire is configured to pull the cuttingwire outwardly from the cutting head to thereby move the cutting wirefrom the stored position to the extended position when the push wire isadvanced distally.
 4. The uterine manipulator of claim 3, wherein thecutting head includes an annular shaped groove formed within the cup,and the cutting wire, when in the stored position, is seated within andaround the annular shaped groove.
 5. The uterine manipulator of claim 4,wherein the cutting head further includes an end cap that at leastpartially defines the annular shape groove.
 6. The uterine manipulatorof claim 5, wherein the cutting head further includes a radiallyoutwardly located lip that forms the annular trench and cooperates witha circumferential periphery of the distal cap to define the annularshaped groove.
 7. The uterine manipulator of claim 6, wherein theannular distal cap and the radially outwardly located lip are composedof a dielectric material.
 8. The uterine manipulator of claim 6, whereinthe cutting head further includes a radially oriented opening formedthrough the end cap, such that the end cap has a radially outward solidportion adjacent the radially oriented opening, and wherein the distalportion of the cutting wire, when in the stored position, extendsradially outwardly from the annular trench, wraps around the radiallyoutward solid portion, and proximally through the radially orientedopening into engagement with the distal portion of the push wire, andwherein distal advancement of the push wire pulls the cutting wiredistally and radially outward from the cup.
 9. The uterine manipulatorof claim 1, wherein the distal portion of the push wire atissue-penetrating tip configured for piercing tissue near the cervix.10. The uterine manipulator of claim 9, wherein the distal portion ofthe push wire has a pre-formed curvature configured to bend radiallyoutwardly.
 11. The uterine manipulator of claim 1, wherein the distalportion of the cutting wire comprises a cuff, and wherein the distalportion of the push wire is configured for being inserted into the cuffin order to pull the distal portion of the cutting wire outwardly fromthe cutting head.
 12. A uterine manipulator, wherein the cutting wire isconfigured for severing a vagina from at least one of the cervix and theuterus when unwound around the longitudinal axis of the shaft.
 13. Asystem comprising: the uterine manipulator of claim 1; and a powersource electrically coupled to the cutting wire.
 14. A method ofseparating a uterus from a vagina of a patient using the uterinemanipulator of claim 1, the method comprising: engaging a cervix of thepatient with the cutting head; distally advancing the distal portion ofthe cutting wire outwardly through tissue of at least one of the vaginaand the cervix and into an abdominal cavity of the patient; applying anelectrical current to the cutting wire, thereby creating an arcdischarge across the annular gap between the cutting wire and theconductive ring; and unwinding the distal portion of the cutting wirearound the longitudinal axis of the shaft, and thus circumferentiallyaround the cervix, while the electrical current is applied to thecutting wire, to thereby sever the vagina from the at least one of theuterus and the cervix.
 15. The method of claim 14, further comprisingvisually locating the distal portion of the cutting wire within theabdominal cavity.
 16. The method of claim 15, further comprising using asurgical instrument to grasp the distal portion of the cutting wirewithin the abdominal cavity, and pulling the cutting wirecircumferentially around the cervix to thereby sever the vagina from theat least one of the uterus the cervix.